# FDA 483 - MEDICA S.p.A. Socio Unico - November 15, 2024

Source: https://www.keypedia.com/records/483/medica-spa-socio-unico/c646245d-7b92-4fb9-8294-68e8790750b7

> FDA 483 for MEDICA S.p.A. Socio Unico on November 15, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MEDICA S.p.A. Socio Unico
- Inspection Date: 2024-11-15
- Product Type: device
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of MEDICA S.p.A. Socio Unico, a medical device manufacturer in Medolla, Italy, revealed significant deficiencies in its quality system. The firm failed to establish adequate procedures for complaint handling and medical device reporting, and its personnel lacked necessary training on US FDA regulations for medical devices. These issues indicate a broad lack of understanding and implementation of critical regulatory requirements for devices intended for the US market.

## Related Officers

- [Dedicated Device Cadre](https://www.keypedia.com/people/dedicated-device-cadre/693932db-dd86-453f-9b51-a63444b07281)
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Company: https://www.keypedia.com/companies/medica-spa-socio-unico/f16ae0e9-7037-4eb1-b68b-3515597bb0e2

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8